@article {DahlP3390, author = {Ronald Dahl and Dalal Jadayel and Vijay Alagappan and Hungta Chen and Donald Banerji}, title = {Once-daily QVA149 provides the same efficacy as the free combination of its monocomponents indacaterol and glycopyrronium: The BEACON study}, volume = {42}, number = {Suppl 57}, elocation-id = {P3390}, year = {2013}, publisher = {European Respiratory Society}, abstract = {IntroductionQVA149 is a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) for the treatment of COPD. This study evaluated the safety and efficacy of once-daily QVA149 vs. the free combination of IND+GLY.MethodsIn this multicenter, double-blind, parallel group, non-inferiority study, patients with moderate-to-severe COPD were randomized (1:1) to QVA149 (110/50{\textmu}g) plus placebo or IND (150{\textmu}g) plus GLY (50{\textmu}g) via the Breezhaler{\textregistered} device for 4wks. 184 randomized patients were planned to give the study 90\% power to rule out that forced expiratory volume in 1 second (FEV1) for QVA149 being 100mL worse than the concurrent administration of IND and GLY. Here we present the lung function results after 4wks.ResultsOf the 193 patients randomized (QVA149 [n=90], IND+GLY [n=103]); mean age: 64.9yrs; mean post-bronchodilator FEV1: 54.0\%, FEV1/forced vital capacity (FVC): 46.0\% predicted; 181 patients were analyzed and 96.9\% completed. At Wk4, QVA149 showed similar improvement in trough FEV1 as compared to IND+GLY (least squares mean [LSM] treatment [Tx] difference 5.0mL; 95\% confidence interval [CI]: {\textendash}51, 40). The LSM-Tx difference of FEV1 area under curve (AUC0{\textendash}4h) for QVA149 vs. IND+GLY at Wk 4 was 12mL; 95\% CI: {\textendash}59, 34. Overall, safety profile was also similar for both groups.ConclusionOnce-daily QVA149 offers the convenience of two bronchodilators in a single device while providing the same improvement in lung function compared to the co-administration of its monocomponents.}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/42/Suppl_57/P3390}, eprint = {https://erj.ersjournals.com/content/42/Suppl_57/P3390.full.pdf}, journal = {European Respiratory Journal} }